MENAFLEX IMPLANT

Description of Event or Problem

THE REPORTING SURGEON (B)(6) IMPLANTED A 9.0MM MEDIAL MENAFLEX DEVICE IN AN OUT-OF-STATE PT, (B)(6) ON (B)(6) 2010. ABSORBABLE PDS SUTURES WERE USED TO SECURE THE INFERIOR SURFACE OF THE IMPLANT AND THE HAY BALE TECHNIQUE WAS USED TO SECURE THE MOST INNER MARGIN OF THE DEVICE TO THE MENISCAL RIM. THE REPORTING SURGEON'S OPERATIVE PROCEDURE WAS INCONSISTENT WITH THE SURGICAL TECHNIQUE RECOMMENDED IN THE MEDIAL MENAFLEX LABELING IN THAT THE LABELING RECOMMENDS THE USE OF NON-ABSORBABLE SUTURE AND DOES NOT SUGGEST THE HAY BALE TECHNIQUE. DURING THE SURGERY, THE REPORTING SURGEON ALSO NOTED THAT A FIBRIN CLOT FROM THE PT'S VENOUS BLOOD WAS ADDED TO THE IMPLANT. USE OF A FIBRIN CLOT ALSO IS NOT PART OF THE RECOMMENDED SURGICAL TECHNIQUE INCLUDED IN THE MEDIAL MENAFLEX LABELING. THE REPORTING SURGEON NOTIFIED REGEN ON MAY 5, 2010 THAT HE WAS INFORMED BY THE PT'S LOCAL SURGEON THAT 11 DAYS POST-IMPLANTATION OF THE MENAFLEX DEVICE, PT (B)(6) DEVELOPED REDNESS, SWELLING AND FEVER WHICH WAS BELIEVED TO BE CONSISTENT WITH A POST-OPERATIVE INFECTION. THE REPORTING SURGEON INDICATED THAT THE INFECTION MAY POSSIBLY BE RELATED TO THE DEVICE OR TO THE PROCEDURE ITSELF, WHICH INVOLVED THE USE OF SEVERAL OTHER POTENTIAL SOURCES OF INFECTION, INCLUDING, THE PDS SUTURE USED TO IMPLANT THE DEVICE AND THE INSTRUMENTS USED TO DRAW, PREPARE AND PLACE THE PT'S VENOUS BLOOD CLOT. THE LOCAL SURGEON SUBMITTED A KNEE ASPIRATE FOR ANALYSIS AND CELL CULTURE. THE ANALYSIS INDICATED ELEVATED WHITE BLOOD CELLS WITH 93% POLYMORPHS. CULTURES HAVE NOT, SO FAR, REVEALED ANY ORGANISMS. THE LOCAL SURGEON PERFORMED AN ARTHROSCOPIC EXAMINATION OF THE AFFECTED KNEE, ON (B)(6) 2010, WHICH REVEALED PURULENT APPEARING FLUID. IN ADDITION, THE MEDIAL MENISCUS HAD AN IRREGULAR APPEARANCE WITH HORIZONTAL AND RADIAL TYPE TEARING IN THE POSTERIOR 1/2 OF THE STRUCTURE. THIS IS CONSISTENT WITH THE MRI AND ARTHROSCOPIC EXAMINATION OF THE JOINT PRIOR TO IMPLANTATION OF THE MENAFLEX DEVICE WHICH INDICATED COMPLEX TEARING OF THE MENISCUS WITH A SIGNIFICANT DEGENERATIVE COMPONENT IN THE POSTERIOR HORN. HE STATED THAT A MENAFLEX DEVICE WAS SUTURED IN THE MENISCUS, BUT THE SUTURES HAD BECOME SOMEWHAT LOOSE AND PORTIONS OF THE DEVICE WERE FREE FLOATING ADJACENT TO THE MENISCUS. ALL FOREIGN MATERIAL, INCLUDING THE SUTURES AND MENAFLEX DEVICE, WERE EXPLANTED, TO REMOVE ANY POTENTIAL SOURCES OF INFECTION, AND THE MENISCUS DEBRIDED BACK TO A STABLE RIM. ACCORDING TO THE REPORTING SURGEON, THE PT IS RECOVERING AND WAS PLACED ON 3 WEEKS OF IV ANTIBIOTICS FOLLOWED BY 3 WEEKS OF ORAL ANTIBIOTICS.

Additional Manufacturer Narrative

THE MANAFLEX DEVICE USED WAS A 9.0MM MEDIAL MENAFLEX IMPLANT PN4301 FROM LOT 3 09E343. (B)(4). THE DEVICE HISTORY RECORDS DID NOT FIND NAY DEVIATIONS OR ANOMALIES THAT COULD POTENTIALLY AFFECT THE STERILITY OF THE DEVICE. ALL RECORDS INDICATE THAT THE PRODUCT MEETS ALL ESTABLISHED SPECS. THE DEVICE WAS TERMINALLY STERILIZED IN ACCORDANCE WITH (B)(6) AND ISO STANDARDS WHICH ARE RECOGNIZED BY THE FDA TO MEET A STERILITY ASSURANCE LEVEL OF 1.0 X 10-6 OR BETTER. THE RECORDS INCLUDED CERTIFICATION FROM THE STERILIZER THAT THE DEVICES IN THIS LOT UNDERWENT STERILIZATION IN ACCORDANCE WITH ESTABLISHED AND VALIDATED STERILIZATION PARAMETERS. (B)(4). BECAUSE NO PRODUCT WAS RETURNED FOR EXAMINATION AND NO ORGANISMS HAVE BEEN IDENTIFIED FROM HOSPITAL TESTING, THE CAUSE OF THIS INCIDENT CANNOT BE REASONABLY IDENTIFIED. POST OPERATIVE INFECTION IS A KNOWN RISK ASSOCIATED WITH ARTHROSCOPIC SURGERY, OR FOR THAT MATTER ANY SURGERY, AND IS IDENTIFIED AS SUCH IN THE PRODUCT LABELING. OUR INTERNAL INVESTIGATION COULD NOT IDENTIFY ANY EVIDENCE OF THE MENAFLEX DEVICE'S CONTRIBUTION TO THE REPORTED INFECTION. REGEN WILL MONITOR ANY FUTURE SUCH RESPONSES TO THE DEVICE, AND THIS LOT SPECIFICALLY; HOWEVER, BASED ON THE CURRENT INVESTIGATION, NO NEED FOR CORRECTIVE ACTION IS WARRANTED. SHOULD ADDITIONAL SUBSTANTIVE INFO BE RECEIVED, THIS COMPLAINT WILL BE REOPENED.